Erin Brockovich, Bayer and Essure horror stories

Bayer contraceptives : Sterilization with sideeffects

By Marc Pitzke, Spiegel online/New York

(AFP)  Consumer activist Erin Brockovich: "We seek dialogue with Bayer "

FiDA highlight/Google translation to English from German

 The legendary U.S. consumer activist Erin Brockovich has a new goal - the German Bayer AG. It's about their contraception Essure . Hundreds of women complain of some horrible side effects.

The gynecologist had promised: Everything would proceed entirely " pure and simple ". Two short, outpatient routine interventions , no anesthesia, done. So uncomplicated, the procedure let themselves almost at lunchtime do.

But after the first appointment, Michelle Garcia doubled in "excruciating pain " . After the second, it only got worse : Suddenly the otherwise dynamic woman was constantly tired , then the pain came back , and eventually she began to bleed uncontrollably hard.

"I almost died," the then 38 -year-old recalls. Fast: "I was lucky. "

What Garcia 2011 almost proved fatal, is in fact actually routine. The single mother from Miami did not want any more children and had therefore opted for the Essure procedure, the only permanent method of contraception without surgery. Two blocking coils are placed in the fallopian tube. " A quick, ten minute procedure in your doctor's office," says the manufacturer , Bayer HealthCare , a U.S. subsidiary of Bayer AG in New Jersey.

Been hundreds of horror stories on record

Michelle Garcia, however, is not the only one in the method went wrong. Hundreds of women have now given Essure horror stories on record, on blogs, websites, Twitter and their own Facebook group : chronic fatigue, depression, weight gain , Fibrositissyndrom , degenerative diseases , autoimmune disorders and menstrual disorders, migraine , allergic reactions, rash, dizziness, fever, unwanted pregnancies , miscarriages. Some of the coils are at least partially migrated through the body.

A petition, Essure " to stop or take this product off the market completely ," now contributes nearly 8000 signatures. The protesters also have prominent flank protection: The consumer activist Erin Brockovich - known by the eponymous film, the 2001 Oscar brought Julia Roberts - has done to their side.

"These women have no chance of recourse," Brockovich complains in an interview with SPIEGEL ONLINE . Since its legendary environmental struggle against U.S. power giant PG & E 20 years ago the infamous for their doggedness Ex - paralegal but has become more circumspect. Cooperation instead of war: "We seek dialogue with Bayer. "

But so far, let Bayer rebuffed them. Therefore Garcia and Angela Lynch travel, one of her fellow-sufferers, now to Germany to confront Supervisory Board Chairman Werner Wenning and the Chief Executive Officer Marijn Dekkers at the Bayer Annual General Meeting on Tuesday in Cologne directly. At the invitation of the activist group Coalition against Bayer Dangers Garcia wants to step up to the microphone there.

Bayer, the problem has indeed saddled probably unintentionally, as it bought up the Essure Conceptus manufacturer last year for $ 1.1 billion. "Bayer and Conceptus have the goal with innovations to promote the health of women," rejoiced Andreas Fibig, the CEO of Bayer HealthCare Pharmaceuticals, still there.

"I do not want others to have to join the same "

"Anyone who feels pain or complications, for whatever reason, our great compassion ," said Edio Zampaglione, Vice President of U.S. Medical Affairs at Bayer winds . Bayer debt wear but no: "There is no birth control method that is one hundred percent effective, and which is also clear in our leaflet. "

Derlei " adverse events," said Zampaglione continued, were also " in clinical trials " and a study by the U.S. Pharmacopeia Drug Administration (FDA?) has already been observed and recognized from the beginning. The turn keeps these side effects for infrequent: Essure is " effective as a means of permanent sterilization to 99.83 percent."

Michelle Garcia took their claims to only five months to find out that their pain decreased on Essure. It turned out, therefore, that a coil broken and had wandered in Garcia's abdomen. Both coils should be removed surgically.

Garcia started in a support group to get involved, which now has more than 7,000 members: "I do not want others must join the same." They also sent in 2013 a long letter to Bayer CEO Dekkers, investor relations chief Alexander Rosar and spokeswoman Tricia McKernan . "Women suffer unspeakable pain and serious discomfort, which they got after Essure was implanted," she wrote and warned Bayer. " You now have a nightmare " One answer they never got.

Why are they now pilgrimage to Cologne, " in the lion's den," she says. For their big entrance at Tuesday Garcia has even trained with a coach public speaking because German language was required: " The women rely on my voice. "

Bayer-Verhütungsmittel: Sterilisation mit Nebenwirkungen

Von Marc Pitzke, New York   (Original German)

Die legendäre US-Verbraucheraktivistin Erin Brockovich hat ein neues Ziel - die deutsche Bayer AG. Es geht um deren Verhütungsmittel Essure. Hunderte Frauen klagen über teils grausige Nebenwirkungen.

AFP

Verbraucheraktivistin Erin Brockovich: "Wir suchen den Dialog mit Bayer"

Der Gynäkologe hatte es versprochen: Alles würde ganz "einfach und simpel" verlaufen. Zwei kurze, ambulante Routine-Eingriffe, keine Narkose, fertig. So unkompliziert, die Prozedur lasse sich quasi in der Mittagspause erledigen.

Doch schon nach dem ersten Termin krümmte sich Michelle Garcia unter "qualvollen Schmerzen". Nach dem zweiten wurde es nur noch schlimmer: Auf einmal war die sonst so dynamische Frau dauernd todmüde, dann kamen die Schmerzen zurück, und schließlich begann sie, unkontrollierbar schwer zu bluten.

"Ich wäre fast gestorben", erinnert sich die damals 38-Jährige. Fast: "Ich hatte Glück."

Was Garcia 2011 beinahe zum Verhängnis wurde, ist in der Tat eigentlich Routine. Die alleinstehende Mutter aus Miami wollte keine Kinder mehr und hatte sich deshalb für das Essure-Verfahren entschieden, die einzig dauerhafte Methode der Empfängnisverhütung ohne Operation. Dabei werden zwei Blockade-Spulen in die Eileiter gesetzt. "Eine schnelle, zehnminütige Prozedur in Ihrer Arztpraxis", versichert der Hersteller Bayer HealthCare, eine US-Tochter der Bayer AG in New Jersey.

Hunderte Horrorstorys zu Protokoll gegeben

Michelle Garcia ist aber nicht die Einzige, bei der die Methode schiefging. Hunderte Frauen haben inzwischen Essure-Horrorstorys zu Protokoll gegeben, auf Blogs, Websites, Twitter und in einer eigenen Facebook-Gruppe: chronische Müdigkeit, Depressionen, Gewichtszunahme, Fibrositissyndrom, Degenerationskrankheiten, Autoimmun- und Menstruationsstörungen, Migräne, allergische Reaktionen, Ausschlag, Schwindelgefühle, Fieber, ungewollte Schwangerschaften, Fehlgeburten. Bei einigen seien die Spulen zumindest teilweise durch den Körper gewandert.

Eine Petition, Essure "zu stoppen oder dieses Produkt ganz vom Markt zu nehmen", trägt mittlerweile fast 8000 Unterschriften. Die Protestler haben außerdem prominenten Flankenschutz: Die Verbraucheraktivistin Erin Brockovich - bekannt durch den gleichnamigen Film, der Julia Roberts 2001 einen Oscar brachte - hat sich auf ihre Seite geschlagen.

"Diese Frauen haben keinerlei Aussichten auf Regress", klagt Brockovich im Gespräch mit SPIEGEL ONLINE. Seit ihrem legendären Umweltkampf gegen den US-Stromriesen PG&E vor 20 Jahren ist die für ihre Verbissenheit berüchtigte Ex-Anwaltsgehilfin aber bedächtiger geworden. Kooperation statt Krieg: "Wir suchen den Dialog mit Bayer."

Doch bisher ließ Bayer sie abblitzen. Deshalb reisen Garcia und Angela Lynch, eine ihrer Leidensgenossinnen, jetzt nach Deutschland, um Aufsichtsratschef Werner Wenning und den Vorstandsvorsitzenden Marijn Dekkers bei der Bayer-Hauptversammlung am Dienstag in Köln direkt zu konfrontieren. Auf Einladung der Aktivistengruppe Coordination gegen Bayer-Gefahren will Garcia dort ans Mikrofon treten.

Bayer hat sich das Problem ja auch eher ungewollt aufgehalst, als es den Essure-Hersteller Conceptus im vergangenen Jahr für 1,1 Milliarden Dollar aufkaufte. "Bayer und Conceptus haben das Ziel, mit Innovationen die Gesundheit von Frauen zu fördern", freute sich Andreas Fibig, der Vorstandschef von Bayer HealthCare Pharmaceuticals, da noch.

"Ich will nicht, dass andere das Gleiche mitmachen müssen"

"Jeder, der Schmerzen oder Komplikationen empfindet, egal aus welchem Grund, hat unser großes Mitgefühl", windet sich Edio Zampaglione, Vice President US Medical Affairs bei Bayer. Schuld trage Bayer aber keine: "Es gibt keine Verhütungsmethode, die hundertprozentig effektiv ist, und das steht auch klar auf unserem Beipackzettel."

Derlei "unerwünschte Ereignisse", so Zampaglione weiter, seien außerdem "in klinischen Tests" und einer Studie der US-Arzneibehörde FDA schon von Anfang an beobachtet und anerkannt worden. Die wiederum hält diese Nebenwirkungen für selten: Essure sei "als Mittel zur permanenten Sterilisierung zu 99,83 Prozent effektiv".

ANZEIGE

Michelle Garcia brauchte ihren Angaben zufolge allein fünf Monate, um herauszufinden, dass ihre Pein auf Essure zurückging. Es stellte sich demnach heraus, dass eine Spule zerbrochen und in Garcias Bauchraum gewandert war. Beide Spulen sollen operativ entfernt worden sein.

Garcia begann sich in einer Hilfsgruppe zu engagieren, die inzwischen mehr als 7000 Mitglieder hat: "Ich will nicht, dass andere das Gleiche mitmachen müssen." Auch schickte sie schon 2013 einen langen Brief an Bayer-Chef Dekkers, Investor-Relations-Chef Alexander Rosar und Sprecherin Tricia McKernan. "Frauen erleiden unsägliche Schmerzen und ernsthafte Beschwerden, die sie bekamen, nachdem Essure implantiert wurde", schrieb sie und warnte Bayer: "Sie besitzen jetzt einen Alptraum." Eine Antwort bekam sie nie.

Weshalb sie nun nach Köln pilgert, "in die Höhle des Löwen", wie sie sagt. Für ihren großen Aufritt am Dienstag hat Garcia sogar mit einem Coach öffentliches Reden trainiert: "Die Frauen verlassen sich auf meine Stimme."

HealthWatchUSA video presentation 2/19/2014 Dr. Stephen Tower on hip implant metal toxicity

WATCH THIS VIDEO ! DR. STEPHEN TOWER ON METAL TOXICITY OF HIP IMPLANTS

ProPublica discloses NQF Conflict-of-interest: Dr. Christine Cassel and Dr. Charles Denham

Payments to CEO Raise New Conflicts at Top HealthQuality Group

by Marshall Allen
ProPublica, Feb. 12, 2014, 1:34 p.m.

                        The top executive at the country’s pre-eminent health care quality organization is being paid hundreds of thousands of dollars by two large medical companies that have a stake in the group’s work.

The payments to Dr. Christine Cassel raise new conflict-of-interest concerns at the National Quality Forum, which endorses benchmarks that Medicare uses to compensate hospitals based on performance.

As ProPublica recently reported, the Quality Forum is reviewing its conflict-of-interest policies after being stung by allegations that the former co-chair of one of its endorsement committees had accepted kickbacks to help a drugmaker win favorable treatment.

Cassel received about $235,000 in compensation and stock last year as a board member for Premier Inc., a North Carolina company that says it provides group purchasing and performance improvement consulting for an alliance of 2,900 hospitals and thousands of nursing facilities and other providers.

Cassel also was paid $189,000 as a board member for the Kaiser Foundation Health Plans and Hospitals in 2012, Quality Forum officials confirmed to ProPublica. Kaiser’s tax forms are not available for 2013, but they show that in 2010 and 2011 Cassel received a total of $357,125.

Cassel, who declined to be interviewed, took over as chief executive officer last summer after a decade as president and CEO of the American Board of Internal Medicine. She also sits on the President’s Council of Advisors on Science and Technology and has been active with the Institute of Medicine.

Quality Forum officials would not say how much Cassel receives to run the Quality Forum, but her predecessor was paid about $525,000 in salary and other compensation in 2011, tax documents show.

The group's chairwoman, Helen Darling, said in an email that the board was “fully aware” of Cassel’s outside compensation when she was hired in December 2012. Darling, president of the National Business Group on Health, initially agreed to an interview but did not respond to follow-up contacts.

Spokeswoman Ann Greiner said the board got a legal opinion and discussed it in depth before agreeing that Cassel could recuse herself “where her outside board service would be construed as an actual or perceived conflict of interest.” So far that hasn’t happened, Greiner said.

Two ethics experts interviewed by ProPublica said Cassel’s relationships with Kaiser and Premier present obvious conflicts given the Quality Forum’s broad involvement in health care.

The Quality Forum maintains a clearinghouse of more than 700 quality measures — covering everything from tracking hospital readmissions to setting information technology standards — that are established by expert committees and widely adopted by U.S. hospitals and other providers.

The ethics experts said they were uncertain how Cassel could recuse herself to anything related to Kaiser and Premier and still do her job.

“Would that mean every time somebody said the word ‘hospital’ she would have to say, ‘I can’t be in this conversation?’” said Eric Campbell, a Harvard School of Medicine professor who has published extensively on conflicts of interest.

“Conflict of interest is as much an appearance as it is an effect,” added Sheldon Krimsky, a medical ethics expert at Tufts University. He called Cassel’s conflicts “absolutely egregious.”

Campbell and Krimsky said the cleanest way to eliminate potential conflicts would be for Cassel to resign from the outside boards. Campbell also said Cassel could continue serve but without pay, which would at least remove possible concerns about the influence of money.

No one has suggested that Cassel has used her post to benefit Kaiser or Premier. But the disclosure of her outside compensation comes as quality is increasingly becoming a bottom-line issue for the industry.

Pay-For-Peformance Shift

Not so long ago, hospitals and other medical providers were paid the same fees by Medicare and other payers based on services they provided, regardless of whether outcomes were good or bad for patients. But as medical errors continued to cause harm and drive up costs, the federal government and others began experimenting with ways to link payments to performance.

That’s where the Quality Forum’s endorsements come in.

Established in 1999, the Washington, D.C., nonprofit invites hundreds of participants from across the health care spectrum — insurers, practitioners, researchers, health care systems and consumer groups — to become members and help pick the best quality benchmarks for endorsement by consensus.

Kaiser and Premier are among the group’s 375 dues-paying member organizations.

In 2009, Medicare awarded a $40 million contract to the Quality Forum to recommend measures it could adopt. President Obama’s health care reform law accelerated the move to pay-for-performance. Medicare already has begun penalizing and rewarding hospitals based on readmission rates, mortality and patient satisfaction measures. By 2017, it’s expected that 9 percent of Medicare payments will be based on performance.

Much of the Quality Forum’s work has been behind the scenes. But that changed last month when allegations arose that questioned the group’s vulnerability to commercial influence.

In settling federal whistleblower lawsuit, the Justice Department accused a well-known patient safety leader, Dr. Chuck Denham, of accepting $11.6 million in kickbacks from a drug company while he co-chaired a Quality Forum committee to endorse patient safety measures.

Denham said he had legitimate contracts with the drug company, but the payments were not disclosed to the Quality Forum. ProPublica found that the group’s final 2010 Safe Practices report endorsed the company’s surgical antiseptic, a decision that other committee members said was unintended.

In response to the Denham case, the Quality Forum launched a review of the committee’s work and the organization’s conflict-of-interest policies. The review is expected to be complete by Feb. 25.

The Quality Forum’s policy for committee members defines a “conflict of interest” as any financial or other interest that could actually, or be perceived to, impede a person’s objectivity or “create an unfair competitive advantage for you or an organization associated with you.”

Cassel’s outside board positions create conflicts, according to ethics experts, because Kaiser and Premier could be affected by Quality Forum endorsements.

Kaiser, an integrated system that’s been touted as modeling the future of health care, had hospital revenue of $18 billion and health insurance plan revenue of $37 billion in 2011. The organization operates in eight states and the District of Columbia at 37 hospitals and hundreds of medical buildings.

Kaiser spent $1.6 million lobbying Congress, the Department of Health & Human Services and other agencies last year, according to the website OpenSecrets.org. A Kaiser executive, Jack Cochran, sits on the Quality Forum’s board.

In an email, Kaiser spokesman John Nelson said the health system was “incredibly fortunate” to have Cassel on its board for the past decade and that “any organization smart enough to engage with her will receive wise counsel and honorable service."

Premier reported revenues of $869 million in the fiscal year ending last June. It spent more than $1 million on lobbying in 2013, according to OpenSecrets.org. In August and November, the company urged members of Congress to instruct Medicare to run any quality measures through the Quality Forum.

Premier featured Cassel’s status as a board member and future top executive of the Quality Forum in documents last May describing its initial public stock offering. In September Cassel acquired 3,704 shares of Premier stock that were then worth about $100,000.

The company’s business involves group purchasing and a consulting arm that uses data analysis to help providers perform better on various quality metrics. In October, a measure sponsored by Premier to track hospital care by the average length of stay was up for renewal by the Quality Forum.

Blair Childs, Premier’s spokesman, said the company is still evaluating the average length of stay metric and that it could be submitted for consideration as a Medicare pay-for-performance measure.

Childs said Cassel’s role on the Premier board doesn’t pose any conflict of interest, and that her relationship with Premier was vetted carefully by the Quality Forum’s board. Cassel was a good addition to the Premier board because of her commitment to improved care and lower costs, he said.

Defining the Strike Zone

Harvard’s Campbell said Cassel’s dual roles aren’t necessarily a problem if disclosed and carefully managed. But he offered a baseball analogy to show why they present a risk for the Quality Forum.

Imagine, Campbell said, training umpires to call balls and strikes — except the person doing the training is also being paid by the New York Yankees, and the strike zone favors the swing of Derek Jeter.

Campbell said he wasn’t being judgmental about Cassel’s conflicts of interest. But the Quality Forum is paid taxpayer dollars by Medicare to perform a public service in a quasi-regulatory role, he said. When the Quality Forum’s leader is paid hundreds of thousands of dollars by hospital companies, Campbell said, it creates a potential incentive to shape the rules in their favor.

Krimsky, the Tufts ethics expert, was more critical of the arrangement. He said it’s not enough for Cassel to recuse herself from decisions or discussions related directly to Kaiser and Premier. She still could be involved in choosing who sits at the table to have discussions or make decisions, he said.

“When there’s a conflict of interest in the management group, that’s a serious problem,” Krimsky said.

Dr. Peter Pronovost, a well-known patient safety leader from Johns Hopkins Medicine, said he did not see how Cassel’s outside board roles would present a direct advantage for Kaiser and Premier. But he said conflicts of interest in the world of quality improvement are often indirect, and the industry hasn’t clearly defined how to navigate them.

“That doesn’t mean (the conflicts) are not real,” Pronovost said. “But they’re less risky. The field does need to articulate the boundaries for these indirect conflicts.”

Although Cassel’s relationships were known to the board, it does not appear that they were widely shared with the Quality Forum’s membership. Cassel’s biography on the Quality Forum website mentions about a dozen other affiliations but not Kaiser and Premier.

Some who are active on Quality Forum committees also said they were unaware.

Leah Binder, president and CEO of The Leapfrog Group, a coalition of employers that advocates for quality and transparency in health care, said she respects Cassel but would have liked to have known about her outside board roles.

“Maybe we need to understand from Chris how she recuses herself from any kind of decision making that might have an impact on those two organizations,” Binder said. “I think she would owe us an explanation of that.”

Lisa McGiffert, director of the Consumers Union Safe Patient Project, sits on a committee that’s recommending possible pay-for-performance metrics to Medicare. Recently a debate about a proposed hospital readmission measure pitted the consumer-minded members, who favored it, against the providers, who were against it. In the end, the consumer side didn’t get its way, she said.

“All of this is about relationships, and (Cassel) has a relationship with that hospital system,” she said. “That relationship means that Kaiser might weigh in with her on those hospital measures.”

McGiffert said all Quality Forum conflict-of-interest disclosure forms should be posted online so anyone can easily see various allegiances.

Rosemary Gibson, an author and senior adviser to The Hastings Center, a research group dedicated to bioethics in the public interest, said she wasn’t surprised at Cassel’s outside compensation. So much money permeates decision-making in Washington, she said, that participants have become oblivious.

“The insiders don’t see it,” Gibson said. “It’s like a fish in water.”

--

ProPublica is investigating health care quality and welcomes your input. Medical providers – help us by completing a brief Provider Questionnaire. Patients can complete ProPublica’s Patient Harm Questionnaire.

Follow @marshall_allen

 Comment:  Joleen Chambers 

At the FDA, trained patient representatives are eliminated because OSHI (Office of Special Health Issues) must 'vet' the participants in medical device advisory panels. Harmed patients are often not selected because of their 'bias' (real-life experience!), but industry insider financial conflicts-of-interest are not an issue that interferes with their full participation. When the established standard is engaged patient advocates having access to define and populate panel discussions at FDA, NQF, IOM, TMIT, PCORI, (etc.) and have equal time at the microphone on webinars with all compensation (and non-compensation) listed in the program, the shame of the disparity will highlight the good medical leaders from the profiteers. For me, a bell weather will be seeing Regina Holliday properly compensated for her leadership and accomplishments! Google her.

Lawyers win on $2.5B J&J hip settlement

Johnson & Johnson Offers $2.5 Billion HipDevice Settlement

By BARRY MEIER  The New York Times

Published: November 19, 2013

                                     

Johnson & Johnson and lawyers for patients injured by a flawed hip implant announced a multibillion-dollar deal Tuesday to settle thousands of lawsuits, but it was not clear whether the deal would satisfy enough claimants.

Under the agreement, the medical products giant will pay some $2.475 billion in compensation to an estimated 8,000 patients who have been forced to have the all-metal artificial hip removed and replaced with another device.

Separately, the company has agreed to pay all medical costs related to such procedures, expenses that could raise the deal’s cost to Johnson & Johnson to some $3 billion, said people familiar with the proposal.

The typical patient payment for pain and suffering caused by the device will be about $250,000 before legal fees, under the plan. Based on standard agreements, plaintiffs’ lawyers would receive about one-third of the overall payout, or more than $800 million, with those who negotiated the plan emerging as big winners.

The settlement plan, which was submitted to a federal judge in Toledo, Ohio, on Tuesday, must receive the support of 94 percent of eligible claimants to go forward. Whether it will reach that goal is unclear. Under the deal, some patients will receive relatively small payouts and others will see payments reduced because the plan imposes a user’s fee on awards based on how long a patient had the implant.

Some patients, many of whom who suffered severe pain and injury from metallic debris generated by the debris, spent years trying to convince doctors there was a problem while Johnson & Johnson was denying one.

The now-recalled device, known as the Articular Surface Replacement, or A.S.R., ranks as one of the most-flawed medical implants sold in recent decades. The DePuy Orthopaedics division of Johnson & Johnson estimated in an internal document in 2011 that the device would fail within five years in 40 percent of the patients who received it.

Traditional artificial hips, which are made of metal and plastic, typically last 15 years or more before requiring replacement. DePuy recalled its device in mid-2010 amid rising failure rates.

The A.S.R. was sold in two versions, one for use in traditional hip replacement and the other for use in an alternative procedure known as hip resurfacing. Beginning in 2003, it was implanted in about 93,000 patients, about one-third of them in the United States.

The A.S.R., which had a metal ball and a metal cup, sheds metallic debris as it wears, generating particles that have damaged tissue in some patients or caused crippling injuries.

The precise value of the settlement is not known because it will vary based on the number of plaintiffs who qualify for it.

DePuy faces some 12,000 A.S. R-related legal claims in the United States. Lawyers estimate that about 8,000 of those claims involve patients who underwent operations to have an A.S.R. removed and replaced.

The remaining plaintiffs, about 4,000 patients, will not receive any compensation, though there is a provision to add $250,000 to the deal for each patient who undergoes a replacement procedure before the plan is finalized. The lawyers believe that Johnson & Johnson will probably have to make a subsequent settlement with added patients as the device fails in them.

Thus far, only two A.S.R. lawsuits have gone to trial. In March, a Los Angeles jury ordered DePuy to pay $8 million in damages to a Montana man after finding that the A.S.R. was defectively designed. Then in August, a Chicago jury sided with DePuy and rejected claims that it had inappropriately marketed the implant.

Under the plan announced Tuesday, the $2.475 billion payment by Johnson & Johnson would be divided into two pots.

The deal would create a $2 billion pool to cover basic awards and a separate $475 million pool to cover additional payments to compensate those patients who sustained more significant injuries related to the device or its removal and replacement.

The average basic award of $250,000 will be affected by a variety of factors. Under the plan, plaintiffs who smoke, are overweight or are older will see their payments reduced.

In addition, patients who had the device longer will also see reductions. For example, the average payment to a patient who had the device for five to six years would fall to $225,000 and be reduced to $200,000 for a patient who had the device six to seven years.

For patients who qualify for the special pool, their payouts would increase based on the severity of their injuries. Lawyers do not know what the number of patients would be to qualify for the pool but they estimate that the figure might be about 10 percent of claimants.

Some of the patients included in the pool would be individuals who had A.S.R.'s on both hips or who had a hip so badly damaged by the device that a procedure to replace it was not completely successful.

Johnson & Johnson’s decision to separately pay all medical costs related to a device replacement is unusual, lawyers said. Typically, such costs are part of a settlement award and a claimant is then liable for paying back an insurer or Medicare for their medical costs.

If the deal is approved, the biggest single payment will probably go to a group of lawyers who negotiated the plan. Under the plan they could receive a 6 percent fee, or about $150 million.
___________________________________
More information:

___________________________________

http://www.jnj.com/news/all/DePuy-Announces-US-Settlement-Agreement-to-Compensate-ASR-Hip-System-Patients-Who-Had-Surgery-to-Replace-Their-ASR-Hip

DePuy Announces U.S. Settlement Agreement to Compensate ASR™ Hip System Patients Who Had Surgery to Replace Their ASR Hip

WARSAW, IN, November 19, 2013 – DePuy Orthopaedics, Inc. (DePuy) and the Court-appointed committee of lawyers representing ASR™ Hip System plaintiffs today announced a settlement agreement to compensate eligible ASR patients in the United States who had surgery to replace their ASR hip, known as revision surgery, as of August 31, 2013.

“We are committed to the well-being of ASR patients, as demonstrated by the voluntary recall and the program providing support for recall-related care,” said Andrew Ekdahl, Worldwide President, DePuy Synthes Joint Reconstruction. “The U.S. settlement program provides compensation for eligible patients without the delay and uncertainty of protracted litigation.  DePuy remains committed to our purpose of advancing innovative treatment options to serve those who need joint replacement surgery.”

The U.S. settlement is valued at approximately $2.5 billion, based on an estimate of 8,000 patients participating in the program.  The amount of the settlement program has been included as part of previously accrued amounts, and no additional charge to the company’s earnings is being recorded in connection with this settlement.  Any remaining related established product liability reserve is based on currently available information and changes to the reserve may be required in the future as additional information becomes available.  The majority of the payments related to this settlement are projected to occur during 2014 from currently available cash.

U.S. Settlement Program

For U.S. ASR Patients Who Had Surgery to Remove Their ASR Hip As of August 31, 2013

The U.S. settlement program is available for U.S. ASR patients who had revision surgery for reasons related to the recall as of August 31, 2013.  Patients eligible for this program can speak with their lawyer, if they have one, or contact the U.S. settlement program claims processor at www.USASRHipSettlement.com or (877) 391-3169.  ASR patients do not need a lawyer to participate in the program. 

For U.S. ASR Patients Who Have Surgery to Remove Their ASR Hip After August 31, 2013

For U.S. patients who have revision surgery after August 31, 2013, the existing Broadspire program providing support for recall-related care is available.  U.S. patients are encouraged to call 1-888-627-2677 for more information. 

For more information about the U.S. settlement program, please visit www.ASRHipInfo.com.

Status of Litigation

Judge David Katz of the U.S. District Court of the Northern District of Ohio is presiding over the federal multidistrict litigation.  The consolidated state litigations are presided over by: Judge Brian Martinotti of the Superior Court of New Jersey, Bergen County; Judge Deborah Mary Dooling of the Circuit Court of Cook County, Illinois; and Judge Richard Kramer of the San Francisco County Superior Court, California.  The settlement agreement was presented to these judges and Maryland State Court Judge, the Honorable Crystal Dixon Mittelstaedt, at a court hearing today. 

The settlement agreement will help bring to a close significant ASR litigation activity in the U.S.  However, some lawsuits in the U.S. will remain. DePuy will continue to defend against remaining claims and believes its actions related to the ASR Hip System have been appropriate and responsible. 

Recall Background

In August 2010, DePuy issued a voluntary recall of the ASR Hip System after receiving new information from the UK National Joint Registry as part of the company’s ongoing surveillance of post-market data concerning the ASR Hip System, which showed a revision rate that was not in line with data previously reported in that registry.  The product continues to perform well in some patients.  Since the recall decision was made, DePuy has worked to provide patients and surgeons with the information and support they need, including the global program providing support for recall-related care, which has thus far resulted in thousands of payments to patients.

DePuy Orthopaedics, Inc. is part of DePuy Synthes Companies of Johnson & Johnson.

(This release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995.  The reader is cautioned not to rely on these forward-looking statements.  These statements are based on current expectations of future events.  If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of DePuy Orthopaedics, Inc. and Johnson & Johnson.  Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents; significant adverse litigation or government action; impact of business combinations; financial distress and bankruptcies experienced by significant customers and suppliers; changes to governmental laws and regulations and domestic and foreign health care reforms; trends toward health care cost containment; increased scrutiny of the health care industry by government agencies; changes in behavior and spending patterns of purchasers of health care products and services; financial instability of international economies and sovereign risk; disruptions due to natural disasters; manufacturing difficulties or delays; complex global supply chains with increasing regulatory requirements; and product efficacy or safety concerns resulting in product recalls or regulatory action.  A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 30, 2012.  Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.investor.jnj.com or on request from Johnson & Johnson.  Neither DePuy Orthopaedics, Inc. nor Johnson & Johnson undertakes to update any forward-looking statements as a result of new information or future events or developments.)

Visit www.ASRHipInfo.com for more information.

###

Press Contacts:
Lorie Gawreluk
732-524-1413
lgawrel1@its.jnj.com

Mindy Tinsley
574-372-7136
mtinsley@its.jnj.com

Investor Contacts:
Louise Mehrotra
732-524-6491
LMehrot@its.jnj.com

Lesley Fishman

732-524-3922

LFishma@its.jnj.com

___________________________________________________________________

https://www.usasrhipsettlement.com/Un-Secure/Documents.aspx

__________________________________________________________________________________

http://www.asrhipinfo.com

DePuy Announces U.S. Settlement Agreement to Compensate ASR™ Hip System Patients Who Had Surgery to Replace Their ASR Hip

November 19, 2013
DePuy Orthopaedics, Inc. (DePuy) and the Court-appointed committee of lawyers representing ASR™ Hip System plaintiffs today announced a settlement agreement to compensate eligible ASR patients in the United States who had surgery to replace their ASR hip, known as revision surgery, as of August 31, 2013.

U.S. Settlement Program Information Sheet for Patients

Contact Information - U.S. Settlement Program Claims Processor
www.USASRHipSettlement.com
(877) 391-3169
claimsprocessor@usasrhipsettlement.com

Read More
_____________________________________________

http://www.modernhealthcare.com/article/20131119/NEWS/311199950?AllowView=VDl3UXpKSzRDLzJCbkJiYkY0M3hla0tvaGtVZEQrWT0=&utm_source=link-20131119-NEWS-311199950&utm_medium=email&utm_campaign=mh-alert J&J to pay $2.5B to settle hip-replacement lawsuits By Jaimy Lee  Modern Healthcare Posted: November 19, 2013 - 5:30 pm ET Johnson & Johnson will pay about $2.5 billion to settle thousands of lawsuits filed by patients who already underwent surgery to replace the company's faulty metal-on-metal hip implants, which failed at higher rates than traditional hip implants and were eventually recalled. About 8,000 patients who had revision surgery before Aug. 31 are part of the settlement, the New Brunswick, N.J.-based healthcare company said. More patients who received Johnson & Johnson's metal-on-metal hip implants are expected to undergo revision surgeries in the future. "The U.S. settlement program provides compensation for eligible patients without the delay and uncertainty of protracted litigation,” said Andrew Ekdahl, worldwide president of the DePuy Synthes Joint Reconstruction business unit, which is part of Johnson & Johnson. The settlement was announced Tuesday after the agreement was presented to the judge overseeing the federal multidistrict litigation consolidated in U.S. District Court in Toledo, Ohio. The settlement comes just weeks after Johnson & Johnson agreed to pay $2.2 billion to settle allegations that it illegally marketed the antipsychotic drug Risperdal and two other medications. Johnson & Johnson, which noted that there are still some ongoing lawsuits in the U.S., said that no additional charge to the company's earnings will be recorded as a result of the settlement. The standard payment for patients who claim a share of the settlement is $250,000. The award may be reduced based on age, smoking status, and the length the device was implanted. Patients may get more than $250,000 if they needed multiple revisions or experienced complications such as a heart attack or pulmonary embolism associated with the revision. They must register their claims by Jan. 6. About 93,000 people, including roughly 12,000 in the U.S., received the ASR XL Acetabular hip implant or the ASR hip resurfacing system, according to Johnson & Johnson's most recent financial filing. DePuy Orthopaedics, a Warsaw, Ind.-based subsidiary of Johnson & Johnson, recalled the metal-on-metal systems in August 2010. It is also facing lawsuits from patients in the United Kingdom, Canada and Australia. Metal-on-metal hip implants have failed at higher rates than traditional implants with plastic bearings, prompting the Food and Drug Administration this year to propose regulations that would require manufacturers of market metal-on-metal hip implants test to provide more information about the safety and effectiveness of these devices. Patients who received the metal-on-metal implants have reported a number of injuries, including adverse local tissue reactions and high ion concentrations of cobalt and chromium. The revision surgeries typically cost about $100,000. Dr. Geoffrey Westrich, director of research for the adult reconstruction and joint replacement division at the Hospital for Special Surgery in New York, said patients having problems with the implants generally experience three types of responses. Some clearly need revision surgery. Others are not symptomatic or suffering any pain, but MRIs indicate that they have adverse tissue reactions and elevated metal ion levels. Those patients may also need revision surgery, Westrich said. A third group of patients may have slightly elevated ion levels and need to be monitored. “There is no definitive answer what to do,” Westrich said. “Without regular follow-ups, we're not going to know who needs a revision.” About 400,000 people received hip implants in 2011, including the roughly 50,000 people who have revision surgeries each year, said Dr. Josh Jacobs, president of American Academy of Orthopaedic Surgeons. While the revision procedures are fairly common, they are often not as successful as primary implants, he said. Follow Jaimy Lee on Twitter: @MHjlee